Medical device licence · 7613 · Class 2
STAPH LATEC TEST
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed July 8, 1999; ended November 8, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 7613
- Licence holder
- Alere Scarborough, Inc.Scarborough, ME, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Test Kit
- First licensed
- July 8, 1999
- Ended
- November 8, 2004
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- WAMPOLE STAPH LATEX TEST
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “staph”. A notice may cover another product or only some lots: read it to see what it covers.
- BIOKIT Colour Staph (2019-07-17)August 9, 2019 · Medical devices · Medical devices · Type III
- BIOKIT COLOUR STAPH ID (2016-04-28)May 20, 2016 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.